Multiple Myeloma in RelapsePhase 2NCT04287855
Multicenter Open Label Phase 2 Study of Isatuximab Plus Pomalidomide and Dexamethasone With Carfilzomib in Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing Isatuximab, Carfilzomib and Pomalidomide in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Poitiers University Hospital at 1 site in France.
Trial summary
Study a quadruplet-based regimen with Minimal Residual Disease (MRD) 10-5 negative rate as primary end point in patients with early Relapsed or Refractory Multiple Myeloma. Therapeutic study, phase II, prospective, multicenter, open-label. The patients will be treated until progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma in Relapse, Multiple Myeloma, Refractory
- What is being tested?
- Isatuximab, Carfilzomib and Pomalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2020to 15 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be able to understand and voluntarily sign an informed consent form
- Must be able to adhere to the study visit schedule and other protocol requirements
- Male or female, age 18 years or older
- Life expectancy of > 6 months.
- Must have a in R1 and R2 relapse Multiple Myeloma with a measurable disease :
- 1 to maximum 2 lines of therapy prior to study entry
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- Relapse Refractory or primary refractory or relapse
- Must have received prior treatment with a Lenalidomide-containing regimen for at least 2 consecutive cycles
- Must have measurable disease as defined by the following: must have a clearly detectable and quantifiable monoclonal M-component value in the serum and/or urine :
- IgG/IgA (serum M-component > 5g/l),
- Light chain (serum M-component >1g/l or Bence Jones > 200mg/24H),
- Serum FLC assay (including for IgD isotypes): involved FLC level > 10 mg/dl provided serum.
- FLC ratio is abnormal for patients not measurable on any of the 3 above criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Wash out period without MM treatment must be of 28 days minimum before C1D1, except for anti CD-38 (See exclusion criteria#10).
- Adequate bone marrow function, documented within 72 hours and without transfusion 72 hours prior to the first intake of investigational product (C1J1) with no growth factor support (one week), defined as :
- Absolute neutrophils ≥ 1 x109/L,
- Untransfused Platelet count ≥ 75 x109/L,
- Hemoglobin ≥ 8.5 g/dL.
- Adequate organ function defined as :
- Serum total bilirubin < 2x upper limit of normal (ULN),
- Clearance creatinine ≥ 30ml/min,
- Serum SGOT/AST or SGPT/ALT < 3x upper limit of normal (ULN).
- Patients affiliated to an appropriate social security system.
- A man who is sexually active with a pregnant female or a FCBP* must agree to use a barrier method of birth control eg, condom with spermicidal foam/gel/film/cream/suppository, even if he has had a vasectomy. All men must also not donate sperm, spermatozoa during the study, for 5 months following treatment discontinuation.
- A woman FCBP* must understand and agree to use 2 reliable effective methods (a very effective method and an effective additional method) of contraception simultaneously without interruption :
- For at least 28 days before starting experimental treatments,
- Throughout the entire duration of experimental treatments,
- During dose interruptions,
- And for at least 5 months after the last dose of experimental treatments.
- All patients must agree to not donate blood during the treatment period, interruptions of treatment and at least 5 months after the last dose of treatment.
- All patients must understand and accept to comply with the conditions of the Pomalidomide pregnancy prevention plan (Appendix of the protocol).
Who cannot join
- Any other uncontrolled medical condition or comorbidity that might interfere with patient's participation, including simultaneous participation to another interventional clinical study.
- Known positive for HIV or active infectious hepatitis, type B or C.
- Patients with non-secretory MM and non-measurable MM
- Patient with terminal renal failure that require dialysis or clearance creatinine < 30 ml/min (calculated with MDRD formula)
- Any uncontrolled or severe cardiovascular or pulmonary disease determined by the investigator including :
- NYHA functional classification III or IV congestive heart failure
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- LVEF (Left Ventricular Ejection Fraction) < 40%
- Uncontrolled angina, hypertension or arrhythmia
- Myocardial infarction in the past 6 months
- Prior history of malignancies, other than multiple myeloma, unless the patients has been free of the disease for ≥ 5 years. Exceptions include the following:
- Basal or squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix or breast
- Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
- Evidence of central nervous system (CNS) involvement
- Ongoing active infection or other clinically significant uncontrolled cardiovascular events
- Unable to comply with IMids regulation to thromboprophylaxis, or teratogenic recommandations.
- Refractory to prior to anti CD38.Patients can be exposed to anti CD38 (any), BUT the wash out period for patient pre-treated with an anti CD38 antibody must be of 4,5 months minimum between last dose of previous anti-CD38 antibody and the first dose of isatuximab.
- Refractory to prior carfilzomib
- Known allergy to one of the study product (pomalidomide, isatuximab, carfilzomib) or dexamethasone
- Patient with a history of severe allergic reactions to thalidomide or lenalidomide
- Exposed to pomalidomide
- Known intolerance to infused protein products, sucrose, histidine, and PS80
- Contraindications to dexamethasone
- Any ongoing non hematological adverse event or medical history grade> 2 severity
- Pregnant or breast-feeding females
- Refusal to participate in the study
- Persons protected by a legal regime (guardianship, trusteeship)
Trial locations and contacts
1 site in 1 country.
About this study
Study a quadruplet-based regimen with Minimal Residual Disease (MRD) 10-5 negative rate as primary end point in patients with early Relapsed or Refractory Multiple Myeloma.
Therapeutic study, phase II, prospective, multicenter, open-label. The patients will be treated until progression. Each cycle of treatment lasts 28 days. Cycle 1 to 13 : treatment phase After cycle 13 : maintenance phase
- Being tested
- Isatuximab, Carfilzomib, Pomalidomide, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsatuximabDrug
Isatuximab by IV route - Cycle 1 : 10mg/kg on days 1, 8, 15 and 22 per 28 days cycle. After cycle 1 : 10mg/kg on days 1 and 15 per 28 days cycle
CarfilzomibDrug
Carfilzomib by IV route - Cycle 1 : 20/27 mg/m² on days 1-2, 8-9, 15-16 per 28 days cycle. Cycle 2-13 : 56mg/m² on days 1, 8, 15 per 28 days cycle. After cycle 13 : 56mg/m² on days 1 and 15 per 28 days cycle.
PomalidomideDrug
Pomalidomide by oral route - Cycle 1-2 : 3mg on days 1 to 21 per 28 days cycle. After cycle 2 : 4mg on days 1 to 21 per 28 days cycle.
DexamethasoneDrug
Dexamethasone by oral route - Cycle 1-13 : 40/20 mg on days 1, 8, 15 and 22. Cycle 2-13 : 56mg/m² on days 1, 8, 15 per 28 days cycle. After cycle 13 : 56mg/m² on days 1 and 15 per 28 days cycle.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Isatuximab, Carfilzomib, Pomalidomide and Dexamethasone Receives: Drug: Isatuximab; Drug: Carfilzomib; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of trial treatment
Fraction of patients who experience a Minimal Residual Disease (MRD) 10-5 per IMWG (International Myeloma Working Group) criteria
Measured: Up to 5 years
Secondary outcomes (3)
Safety of trial treatment
List of AE frequency (AE assessed by Common Terminology Criteria for Adverse Events (CTCAE) criteria, version 5.0)
Measured: Up to 5 years
Depth of response to the trial treatment
Per International Myeloma Working Group (IMWG) criteria
Measured: Up to 5 years
Progression Free survival
Time to relapse or death, whichever occurs first
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start28 Aug 2020
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma in RelapseStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LELEU Xavier, Prof., Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287855
- Sponsor's protocol ID
- IsKPd - IFM2018-03
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2020
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Open Label Phase 2 Study of Isatuximab Plus Pomalidomide and Dexamethasone With Carfilzomib in Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04287855
- Acronym / sponsor ID
- IsKPd - IFM2018-03
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- Sanofi, Celgene, Amgen, Intergroupe Francophone du Myelome
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study a quadruplet-based regimen with Minimal Residual Disease (MRD) 10-5 negative rate as primary end point in patients with early Relapsed or Refractory Multiple Myeloma.
Therapeutic study, phase II, prospective, multicenter, open-label. The patients will be treated until progression. Each cycle of treatment lasts 28 days. Cycle 1 to 13 : treatment phase After cycle 13 : maintenance phase
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Isatuximab, Drug: Carfilzomib, Drug: Pomalidomide, Drug: DexamethasoneIsatuximab, Carfilzomib, Pomalidomide and Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Must be able to understand and voluntarily sign an informed consent form
- Must be able to adhere to the study visit schedule and other protocol requirements
- Male or female, age 18 years or older
- Life expectancy of > 6 months.
- Must have a in R1 and R2 relapse Multiple Myeloma with a measurable disease :
Key exclusion criteria (27 listed)
- Any other uncontrolled medical condition or comorbidity that might interfere with patient's participation, including simultaneous participation to another interventional clinical study.
- Known positive for HIV or active infectious hepatitis, type B or C.
- Patients with non-secretory MM and non-measurable MM
- Patient with terminal renal failure that require dialysis or clearance creatinine < 30 ml/min (calculated with MDRD formula)
- Any uncontrolled or severe cardiovascular or pulmonary disease determined by the investigator including :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsatuximabIsatuximab by IV route - Cycle 1 : 10mg/kg on days 1, 8, 15 and 22 per 28 days cycle. After cycle 1 : 10mg/kg on days 1 and 15 per 28 days cycle | Drug | Intervention |
| CarfilzomibCarfilzomib by IV route - Cycle 1 : 20/27 mg/m² on days 1-2, 8-9, 15-16 per 28 days cycle. Cycle 2-13 : 56mg/m² on days 1, 8, 15 per 28 days cycle. After cycle 13 : 56mg/m² on days 1 and 15 per 28 days cycle. | Drug | Intervention |
| PomalidomidePomalidomide by oral route - Cycle 1-2 : 3mg on days 1 to 21 per 28 days cycle. After cycle 2 : 4mg on days 1 to 21 per 28 days cycle. | Drug | Intervention |
| DexamethasoneDexamethasone by oral route - Cycle 1-13 : 40/20 mg on days 1, 8, 15 and 22. Cycle 2-13 : 56mg/m² on days 1, 8, 15 per 28 days cycle. After cycle 13 : 56mg/m² on days 1 and 15 per 28 days cycle. | Drug | Intervention |
Primary outcome
Efficacy of trial treatment
Time frame: Up to 5 years
Fraction of patients who experience a Minimal Residual Disease (MRD) 10-5 per IMWG (International Myeloma Working Group) criteria
3 secondary outcomes
Safety of trial treatment
Time frame: Up to 5 years
Depth of response to the trial treatment
Time frame: Up to 5 years
Progression Free survival
Time frame: Up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LELEU Xavier, Prof. principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isatuximab, Carfilzomib and Pomalidomide in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of trial treatment (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.